Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-T-lymphocyte-globulin (ATG Fresenius) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study - not available

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005719-83-DE

Enrollment

160

Registered

2006-08-15

Start date

2007-01-30

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lymphoblastic and myeloid leukemia MedDRA version: 8.1 Level: LLT Classification code 10024330 Term: Leukemia acute

Interventions

Trade Name: ATG Fresenius S Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Acute myeloid leukemia in first or subsequent complete remission (de-novo or secondary AML). Acute lymphoblastic leukemia in first or subsequent complete remission. Patient's age: 18 – 65 years. Myeloablative standard conditioning. HLA-identical sibling (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1). No major organ dysfunctions. Patient's written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No complete remission at time of randomization. Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as o Total bilirubin, SGPT or SGOT > 5 times upper the normal level. o Left ventricular ejection fraction < 30 %. o Creatinine clearance < 30 ml/min. o DLCO < 35 % and/or receiving supplementary continuous oxygen. Positive serology for HIV. Pregnant or lactating women. Serious psychiatric or psychological disorders. Progressive invasive fungal infection at time of registration

Design outcomes

Primary

Measure	Time frame
Main Objective: The study should demonstrate that the use of ATG FRESENIUS will reduce the risk of chronic graft-versus-host disease after allogeneic stem cell transplantation from HLA-identical sibling.;Secondary Objective: Secondary objectives :· Comparison of acute graft-versus-host disease on day +100 after stem cell transplantation according to the acc. to the Glucksberg scale · Comparison of quality of life between both treatment arms according to the EORTC. Comparison of treatment-related mortality on day +100 and day +365 after allogeneic peripheral blood stem cell transplantation. Comparison of toxicity according to the Bearman-Score. Comparison of overall survival post-transplant at two years.· Comparison of progression-free survival post-transplant at two years.· Comparison of engraftment (leukocyte count > 1.0 x 109/l, platelet count > 20 x x 109/l). Comparison of incidence of bacterial, viral, fungal and protozoal infection at day +100 and at one year after transplantation. Comparison of chronic-GvHD-free survival between the two treatment arms at two years. Incidence of adverse events (AEs) and adverse drug reactions (ADRs) between the two treatment arms.;Primary end point(s): Comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic peripheral blood stem cell transplantation from HLA-identical siblings with or without anti-T-lymphocyte-globulin according to the revised Seattle criteria of Lee et al. and of the NIH Consensus Development Project at two years after transplantation.	—

Measure

Time frame

Main Objective: The study should demonstrate that the use of ATG FRESENIUS will reduce the risk of chronic graft-versus-host disease after allogeneic stem cell transplantation from HLA-identical sibling.;Secondary Objective: Secondary objectives :· Comparison of acute graft-versus-host disease on day +100 after stem cell transplantation according to the acc. to the Glucksberg scale · Comparison of quality of life between both treatment arms according to the EORTC. Comparison of treatment-related mortality on day +100 and day +365 after allogeneic peripheral blood stem cell transplantation. Comparison of toxicity according to the Bearman-Score. Comparison of overall survival post-transplant at two years.· Comparison of progression-free survival post-transplant at two years.· Comparison of engraftment (leukocyte count > 1.0 x 109/l, platelet count > 20 x x 109/l). Comparison of incidence of bacterial, viral, fungal and protozoal infection at day +100 and at one year after transplantation. Comparison of chronic-GvHD-free survival between the two treatment arms at two years. Incidence of adverse events (AEs) and adverse drug reactions (ADRs) between the two treatment arms.;Primary end point(s): Comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic peripheral blood stem cell transplantation from HLA-identical siblings with or without anti-T-lymphocyte-globulin according to the revised Seattle criteria of Lee et al. and of the NIH Consensus Development Project at two years after transplantation.

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Countries

Germany, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026